Study summary:

OBJECTIVES: I. Determine whether intervention with a low-fat balanced diet will prolong the
disease-free survival time in patients presenting with nonmelanomatous skin cancer and
having a history of not more than two previous skin cancers. II. Assess the effect of this
intervention on numbers of tumors during the two year follow-up period. III. Determine the
incidence of new skin cancer in the control, nonintervention population.
OUTLINE: This is a randomized study. Patients are randomized into the Dietary Intervention
or Nonintervention groups. The control group has initial and follow up assessment of eating
habits. The dietary intervention group also has initial and follow up assessment of eating
habits that have been changed to reduce fat intake to one-half of the amount in the average
American diet with a subsequent increase of carbohydrates to compensate for total caloric
intake. Both groups have assessment of clinical status of skin cancer at 4 month intervals
for 24 months. Patients are followed for two years.
PROJECTED ACCRUAL: Approximately 175 patients will be accrued in the first 3 years of this
study.

Criteria:

DISEASE CHARACTERISTICS: Histologically confirmed basal cell carcinoma or squamous cell
carcinoma of the skin No more than two prior skin carcinomas Must not have genetic
predisposition to skin cancer (i.e., xeroderma pigmentosum, basal cell nevous syndrome)
PATIENT CHARACTERISTICS: Age: 15 and over Race: Caucasian Performance status: Not
specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not
specified Renal: Not specified Other: No therapeutic diet that requires fat intake greater
than 20% of total calories No untreated systemic malignancy No history of arsenic
ingestion Not diabetic
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified
Endocrine therapy: No concurrent systemic steroids Radiotherapy: No prior x-ray therapy
for acne No prior/concurrent ultraviolet light (PUVA or UVB) therapy for psoriasis
Surgery: Not specified Other: No concurrent megavitamin or mineral supplementation At
least 5 years since treatment with antimetabolites, folic acid inhibitors, alkalating
agents, etc.

NCT ID:

NCT00003097

Primary Contact:

Study ChairHomer Black, PhDBaylor College of Medicine

Backup Contact:

N/A

Location Contact:

Houston, Texas 77030United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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